Mouthpiece cover for an inhaler

ABSTRACT

A mouthpiece cover for an inhaler is described. The mouthpiece cover is designed for use with a dry powder inhaler and is provided with structural features to prevent a patient from inhaling the cover.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. provisional patent application No. 62/105,675, filed Jan. 20, 2015 and U.S. provisional patent application No. 62/059,104, filed Oct. 2, 2014, the entire disclosures each of which are incorporated herein by reference in their entirety.

TECHNICAL FIELD

The present disclosure relates to a mouthpiece cover for an inhaler. In particular, the mouthpiece cover is suitable for a dry powder inhalation system for delivering pharmaceuticals to the respiratory tract and lungs for the treatment of local or systemic diseases or disorders.

BACKGROUND

Combination products including a device and a drug formulation for treating diseases and disorders are more commonly used by patients without the need to visit a health professional, a clinic, or a physician. These products are provided as injectables for systemic delivery, or as inhalers for local lung delivery for self-administration. For example, inhalation systems for pulmonary delivery for the treatment of local lung disease or disorders, including chronic obstructive pulmonary disease and asthma, consist of metered dose inhalers consisting of a dry powder formulation and a propellant in the form an aerosol, for example, SYMBICORT®. Drug delivery to the lungs also has been achieved with dry powder inhalers without propellants for the treatment of asthma with, for example, the Advair DISKUS®.

Dry powder inhalers can be breath activated or breath-powered and can deliver drugs by converting drug particles in a carrier into a fine dry powder which is entrained into an air flow and inhaled by the patient. Drugs delivered with the use of a dry powder inhaler are no longer only intended to treat pulmonary disease, but can also be absorbed into the systemic circulation so they can be used to treat many conditions, including diabetes (EXUBERA® and AFREZZA® inhalers).

Dry powder inhalers are made of multiple parts and some mouthpiece designs/prototypes have a tendency to trap and deposit debris at the end of the mouthpiece during storage. Some multiple dose inhalers are designed to include a mouthpiece cover for preventing foreign material to ingress into the mouthpiece, or prevent contamination during inhaler storage between uses. It is thought that some inhaler users may attempt to use the inhaler without removing the mouthpiece cover, which can lead to the mouthpiece cover being inadvertently aspirated by the user during dosing. The potential for inhalation of the cover has led to the need for designing an inhaler mouthpiece cover with improvements to prevent easy dislodgement or removal of the cover, and to prevent inhalation of the mouthpiece cover should the user inadvertently forget to remove it during inhaler use.

SUMMARY

Described herein are mouthpiece covers for inhalers. In some embodiments, the mouthpiece covers are adaptable to dry powder inhalers for use in pulmonary delivery of drug formulations.

In one embodiment, mouthpiece covers are disclosed comprising, a body substantially shaped as a hollow wedge having a front side and a back side. The mouthpiece covers can include a mouthpiece insertable portion wherein a mouthpiece can be inserted. The mouthpiece insertable portions can further include an open end, a closed end, and a grip-tab The mouthpiece insertable portion can also include a top portion which is tapered towards the front side, a bottom portion, left side wall and right side wall, an interior surface, and an external surface to form a scoop-like structure that fits tightly around the mouthpiece end of an inhaler for placing into the mouth.

In some embodiments, the mouthpiece cover is made of plastic(s) including, but not limited to high density polyethylenes. The mouthpiece covers can comprise an insertable portion comprising one or more rib-like structures or ridges projecting from the interior surface of the insertable portion to create a tight junction between the mouthpiece cover and the inhaler mouthpiece. This tight junction can prevent the mouthpiece cover from easily dislodging from the inhaler. In some embodiments, the interior surface of the insertable portion can comprise detents to form friction with the inhaler mouthpiece to prevent movement of the cover in an inserted position unless a separating, pulling force is applied.

In various embodiments, an inhaler mouthpiece cover comprises a grip-tab configured for handling the cover during placement of the cover onto the inhaler mouthpiece and removal of the cover from the inhaler mouthpiece. In some embodiments, the grip-tab can be configured to extend outwardly from the closed end of the body. Further, the grip-tab can optionally have raised structures of any type, or ridges optionally of any size and type, including of varying heights that can be parallel to the closed end of the cover and may be continuous or non-continuous. In one embodiment, grip-tabs can be of any size and shape, but can generally be larger in width than the inhaler mouthpiece width and/or larger in width than the width of the insertable portion of the body. The grip-tab can be of any shape that allows gripping of the mouthpiece cover. In one embodiment, the grip-tab has a rectilinear shape and is flat. In other embodiments, the grip-tab is relatively flat and substantially trapezoidal in shape, in particular, an isosceles trapezoid structure. Alternative shapes can include, but are not limited to substantially square, substantially rectangular, a substantially truncated circle, and a substantially truncated oval.

In some embodiments, the grip-tab is greater than 1.2 times the width of the insertable portion. In another embodiment, the grip-tab is greater than 10% wider, greater than 25% wider, or greater than 40% wider than the width of the insertable portion of the cover. In some embodiments, the grip-tab is greater than 20% wider than the width of the inhaler mouthpiece.

In an embodiment, the grip-tab can have and upper surface and a bottom surface both of which can be substantially flat and extend outwardly and laterally from the mouthpiece cover closed end and bottom portion respectively. In some embodiments, the upper surface and a bottom surface can be continuous with the insertable portion or body. In this embodiment, the mouthpiece cover is configured so that if a user puts it in his/her mouth its structure prevents the user from closing the lip to acquire a tight seal.

In certain embodiments, the mouthpiece cover comprises an injection-molded plastic material comprising a color dye to distinguish the cover from the mouthpiece of the inhaler. In such embodiments, the color of the mouthpiece cover can be different than the color of the mouthpiece it is attached to.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front perspective view of a mouthpiece cover embodiment described herewith.

FIG. 2 is a bottom perspective view of the mouthpiece cover of FIG. 1.

FIG. 3 is a top view of the mouthpiece cover of FIG. 1.

FIG. 4 is a bottom view of the mouthpiece cover of FIG. 1.

FIG. 5 is a first side view of the mouthpiece cover of FIG. 1.

FIG. 6 is a second side view of the mouthpiece cover of FIG. 1.

FIG. 7 is a rear view of the mouthpiece cover of FIG. 1.

FIG. 8 is a front view of the mouthpiece cover of FIG. 1.

FIG. 9 is a top view of the mouthpiece cover of FIG. 1 mounted on an inhaler designed for pulmonary inhalation use.

FIG. 10 is a side view of the mouthpiece cover of FIG. 1 mounted on an inhaler designed for pulmonary inhalation.

FIG. 11 is a bottom view of the mouthpiece cover of FIG. 1 mounted on an inhaler designed for pulmonary inhalation.

DETAILED DESCRIPTION

In embodiments disclosed herein, mouthpiece covers for inhalers are disclosed wherein the covers comprise features for preventing a user from inhaling a cover during use of an inhaler. The mouthpiece covers are detachable and may or may not be tethered to its corresponding inhaler. The mouthpiece covers are also designed to prevent ingress of foreign material into the flow path of the inhalation device while the inhaler is stored before or between uses, material that could inadvertently be inhaled by a user. The covers also prevent contamination of the flow path by foreign microbial agents in storage conditions and configurations. The mouthpiece covers also allow for ease of removal and replacement on and off the inhaler and are discrete and convenient to use.

In one embodiment, the mouthpiece cover is removable with every use of an inhaler and replaceable on the inhaler. In an embodiment, and as shown in FIG. 1, there is provided a front perspective view of a mouthpiece cover 10 formed as a single piece by injection molding plastic, for example, high density polyethylene or polypropylene. In other embodiments, mouthpieces covers as described can be formed by cast molding or 3D printing. In this and other embodiments, mouthpiece cover 10 can be substantially shaped as a bra-like, reed-like, or scoop-like structure, so that if a user attempts to use an inhaler adapted with this design, a grip-tab would more than likely be inserted into the mouth of the individual.

In the embodiment illustrated in FIG. 1, the mouthpiece cover comprises a body or insertable portion 12 structured to fit an inhaler mouthpiece. The mouthpiece cover includes a front end 13, a back end 14 which is sealed, and a grip-tab 15 extending outwardly from front end 13 of body 12 to form a rectilinear, e.g., trapezoidal, structure. The grip-tab can comprise a substantially flat structure comprising a top surface 19 configured with raised structures or ridges 17, 17′ to provide a gripping, roughened, anti-slip area on top surface 19 for secure handling. Body 12 comprises a chamber closed at the front end 13 by a flat, angular wall 24, which is at a substantially obtuse angle 19 from grip-tab 15. Obtuse angle 19 can be greater than 91 degrees, greater than 95 degrees, greater than 100 degrees, between about 91 degrees and about 100 degrees, between about 95 degrees and 100 degrees, or between about 91 degrees and about 170 degrees. In one embodiment, obtuse angle is greater than about 95 degrees.

Body 12 further comprises an interior surface 20, an exterior surface 22, and a bottom surface 26. In some embodiments, bottom surface 26 can be relatively flat.

FIG. 1 also shows body 12 has an opening 18 substantially tapered towards the back end 14, which allows access to the internal volume of the body 12 for insertion of an inhaler mouthpiece into the mouthpiece cover 10. In this embodiment, the grip-tab 15 is larger in width than body 12. In some embodiments, grip-tab 15 is greater than 1.2 times the width of body 12, greater than 20% the width of body 12, or greater than 40% the width of body 12.

In other embodiments, a mouthpiece cover can include a cover over the top surface of an inhaler mouthpiece instead of the bottom surface.

In various embodiments, the opening may not be tapered toward the back end 14.

In some embodiments, grip-tab 15 can extend laterally from body 12. In other embodiments, grip-tab 15 can extend outwardly from body 12 to form non-trapezoidal shapes such as, but not limited to substantially square, substantially rectangular, substantially triangular, substantially half-circular, substantially half-oval, and the like. Virtually any shape can be used as long as it provides a large-enough surface so as to be readily gripped, for example, between a finger and thumb.

In various embodiments, the structure formed by grip-tab 15 extending outwardly from said body 12 can be other shapes and configurations than merely substantially flat. For example, the structure can be curved to embrace the curvature, for example, of a finger. Also, the structure can thicken as it extends outwardly or at the edge of the tab to aid in gripping and removal.

In some embodiments, raised structures or ridges 17, 17′ can be aided by or replaced by other forms of anti-slip surfaces. For example, ridges 17, 17′ can be replaced by raised, substantially round dots or other shaped raised surfaces. In other embodiments, roughened surfaces can be used as anti-slip surfaces. In various embodiments, an anti-slip surface and/or ridges 17, 17′ may not be present.

FIG. 2 is a bottom perspective view of the mouthpiece cover of FIG. 1 and illustrates bottom surface 26 of body 12. Bottom surface 26 can comprise one or more indentations 28,28′, which are substantially arranged parallel along the width of body 12 and form recessed structures or indentations opposite in configuration to those on the top surface 19 of grip tab 15. Indentations 28,28′ structurally create a friction grip contact. In other embodiments, grip contacts can be provided, for example, with ridges and/or indentations on both the top and bottom surfaces or with indentations on the top and ridges on the bottom. In some embodiments, the ridges on the top surface do not necessarily mirror the indentations on the bottom surface.

FIGS. 5 and 6 illustrate side views of mouthpiece cover 10 showing its various features. These various features include body 12 which can be tapered, grip-tab 15 comprising ridges 17, 17′, and closed end 24 of body 12 substantially angular relative to flat grip-tab 15. In one embodiment, the angle of closed end wall 24 is obtuse angle 19 and preferably greater than 95 degrees relative to the grip-tab.

FIG. 7 illustrates a rear view of mouthpiece cover 10 showing a substantially oval interior volume of body 12 configured to adapt tightly to an inhaler and showing grip-tab 15 extending laterally from body 12 from bottom surface 26. Also illustrated are protrusions 60, 60′ that can aid in providing a tight fit between the inhaler mouthpiece and the inside of the mouthpiece cover. In some embodiments, more than two protrusions can be provided and/or the protrusions need not be placed at the locations indicated but can be placed at various locations inside.

FIG. 8 is a front view of mouthpiece cover 10. Mouthpiece cover 10 includes body 12 which comprises a sealed end 24 which covers the outlet of an inhaler mouthpiece. As seen in FIG. 8, the grip-tab extends outwardly and laterally from the mouthpiece cover body 12 from its bottom portion. In some embodiments, grip-tab 15 can extend from the top portions of body 12. In other embodiments, grip-tab 15 can extend from intermediate portions of the body.

FIGS. 9, 10 and 11, respectively are top, side and bottom views of mouthpiece cover 10 as shown in FIG. 1 mounted on an inhaler mouthpiece 55. In some embodiments, inhaler 50 can be designed for oral, or pulmonary inhalation use.

In an embodiment, grip-tab 15 includes an upper or top surface 19 and underside or bottom surfaces that are substantially flat and extend outwardly and laterally from body 12 when mounted on inhaler 50. The lateral extension can provide greater surface area for gripping. This greater surface area can also provide visual cueing that the mouthpiece cover is a separate part from the mouthpiece to which it is attached and suggesting that the mouthpiece cover should be removed from the inhaler prior to inhalation.

As described above, grip-tab 15 can have virtually any shape but will preferably have rounded corners and lack notches or extensions in order to avoid snagging on other objects in a purse or pocket, etc. and dislodging the cover from the mouthpiece. Thus, in some embodiments, a lateral extension is sufficient to provide an optimal surface area for gripping, for example, between a finger and thumb. In some embodiments, the lateral extension is no wider than a surface area optimized for gripping. The shape of the grip-tab will preferably present a reed-like appearance to encourage a user, who has forgotten to remove the cover or not realized that the cover should be removed, to place his/her lips on the grip-tab and thereby deter inhalation of the cover.

In this and other embodiments, mouthpiece cover 10 can be designed to be fitted onto the inhaler mouthpiece in its entirety or partially on the mouthpiece so as to cover a portion of the inhaler mouthpiece. In some embodiments, the mouthpiece has an outside dimension that increases as it extends from the inhaler body to its end on which the cover mounts. In such embodiments, a cover that extends over the mouthpiece equally on all sides could create a cavity in which dust and other foreign matter could collect. This can be avoided by providing only minimal coverage on one side of the cover, preferably the side corresponding to a tapering outside dimension of the mouthpiece. Such an arrangement is seen in FIGS. 1-4, 9, 10, for example. In one embodiment, the mouthpiece cover comprises a closed end having a beveled front wall configured to allow easy purchase of a finger on the grip-tab, or of a lip to prevent a subject from inhaling the cover when the cover is mounted in the inhaler.

In some embodiments, a number of patient factors including, but not limited to diabetic neuropathy, age, arthritis, and amputation were also considered in the design of a suitable cover. For example, an unimpaired adult can exert key pinch grip forces of around 16 pounds. In preferred embodiments, the cover can be removed using key pinch grip forces that do not exceed 10, 9, 8, 7, or 6 pounds. In embodiments disclosed herein, mouthpiece cover 10 is designed for use with an inhaler for pulmonary delivery of drugs by oral inhalation for the treatment of various diseases, including diabetes. In exemplary embodiments, the inhaler is used for delivering, for example, dry powder formulations comprising, insulin, GLP-1, parathyroid hormone, and the like.

In one embodiment, the mouthpiece cover is provided with structural features which provide acceptable friction force levels and propensity for the cover to remain in place during storage. Too large a removal force can frustrate a user and/or cause patient pain. Conversely, too little a force can allow the cover to fall off easily during storage. In one embodiment, the mouthpiece cover is provided with removal/replacement forces that prevent the cover from dislodging and remain securely attached to an inhaler during storage without preventing a patient from removing it and reinstalling it. In some embodiments, an interior surface comprises ridges and/or detents, such as protrusions 60,60′ in FIG. 7, which promote a tight/friction fitting of the cover on the inhaler mouthpiece. In some embodiments, when a mouthpiece cover is provided with protrusions 60,60′, an inhaler with corresponding indentations on the mouthpiece surface can be provided. Therein, protrustions on the inner surface of the mouthpiece cover can wed with indentations on the mouthpiece. The opposite configuration can also be provided where the mouthpiece includes protrusions and the inner surface of the mouthpiece cover includes corresponding indentations.

In some embodiments, a pull force of at least 0.25, 0.5, 0.75 or 1 pound is required to remove the cover. In other embodiments, a pull force of not more than 2.5, 3, 3.5, 4, or 4.5 pounds is required to remove the cover. In some embodiments, the mouthpiece cover 10 further comprises rib-like structures, or a roughened granular surface configured on the top surface and/or bottom surface of the grip-tab. More generally any surface treatment or texturing of the top or bottom surfaces, or both, of the grip tab that provide sufficient friction to facilitate removal may be employed in various embodiments. Similarly, the cover may be made from a material that provides sufficient friction even when smooth.

In the embodiments described herein, the mouthpiece cover comprises a grip tab which provides a suitable surface for grasping the cover during removal/replacement while minimizing handling at the open end of the cover. In one embodiment, the grip tab is designed similarly as a reed on a musical instrument. For users who may fail to recognize that the cover needs to be removed before use of the inhaler device, this feature encourages placement of the lips on the grip tab and deters patients from inserting the whole cover into their mouth.

In some embodiments, to prevent inadvertent aspiration of the cover if a user places the entire cover into their mouth, the mouthpiece cover comprises a preventive mechanism to prevent a lip seal beyond the cover since inhalation of cover can occur if a lip seal is formed around the mouthpiece and the user inhales. In one embodiment, the mouthpiece cover deters users from inserting the entire mouthpiece with its cover in their mouth, by providing the cover with an exaggerated reed-like grip tab that can be difficult or uncomfortable to insert into his/her mouth. In some embodiments, in addition to the reed-like grip tab, the mouthpiece cover can include an underside or bottom portion of the cover that extends over the mouthpiece to abut the inhaler body which can prevent the lips of the user from sealing. In various embodiments, the cover can extend over the top portion or both the top and bottom portion of the mouthpiece to prevent the lips of the user from sealing on the mouthpiece with the entire cover inside their mouth.

In one embodiment, the mouthpiece cover can comprise a colorant or dye of any type suitable for pharmaceutical use and different from the color of the inhaler for differentiating the inhaler used. For example, in some embodiments, a cover provided in one color can define an inhaler with a first medicament and/or active agent and a cover in another color can define an inhaler with a second, different medicament and/or active agent. In other embodiments, a different colored inhaler can define a dose of a particular medicament and/or active agent. For example, a cover provided in one color can define an inhaler with a first amount of a medicament and/or active agent and a cover in another color can define an inhaler with a second, different amount of medicament and/or active agent. Various combinations of colors for inhaler covers can be used to identify the medicament and/or active agent, and/or the amount of medicament and/or active agent within an inhaler.

In one embodiment, the colorant is incorporated in the molten plastic blend prior to injection molding the cover.

In other embodiments, the cover color is different from that of the inhaler mouthpiece to provide visual cueing that it is a separate part that should be removed before inhalation.

In embodiments comprising a tether, the mouthpiece cover can be attached to the inhaler by tethering including, for example, a short tether placed in suitable surfaces of an inhaler, for example, fitted around the inhaler mouthpiece or the housing of an inhaler. In another embodiment, a hinge design for attachment of the cover can be adapted to the inhaler which does not impart any interruption in functioning of the mouthpiece.

In these embodiments, a mouthpiece cover can be provided as an exaggerated reed-like grip tab feature to deter users from inserting the entire cover into their mouth and to provide greater visual cueing that the cover is meant to be removed.

In another embodiment, the mouthpiece cover is provided as a bra-like fit on the mouthpiece to better assure proper orientation during replacement. Inadvertent aspiration cannot occur when the cover is oriented properly because a lip seal beyond the cover and on the mouthpiece is not possible. In some embodiments, inadvertent aspiration cannot occur when the cover is oriented properly because it may be difficult to get a lip seal on the mouthpiece beyond the reed. In one embodiment, the underside or bottom portion of the cover when mounted on an inhaler extends over the inhaler mouthpiece to the inhaler body and is effective at preventing the lips from sealing on the mouthpiece. In this and other embodiments, mouthpiece cover 10 shortens the top portion of the body which results in less contact with the tip of the mouthpiece if the cover is replaced upside down causing the cover to fall off. In some embodiments, the cover can fall off if placed upside down on the mouthpiece because the beveled end of the cover may not match with the beveled end of the inhaler mouthpiece thereby preventing complete securing of the cover. The inability of a user to replace the cover in an upside down fashion provides greater cueing that it has been replaced incorrectly and encourages them to turn it right side up.

In some embodiments, the bra-like, or contour-following, fit of the cover on the mouthpiece includes a beveled or angled wall at the interior end of the insertable portion of the cover if the mouthpiece itself has a beveled end. A beveled end on a mouthpiece can inhibit tongue seal-off of the opening of the mouthpiece facilitating more consistent and efficient inhalation of the medicament.

Some embodiments comprise a cover according to any of the embodiments disclosed herein mounted on the mouthpiece of an inhaler. In some embodiments, the inhaler is a reusable inhaler. In some aspects of these embodiments, the inhaler is a multi-dose inhaler. In other aspects of these embodiments, the inhaler is a unit dose, reloadable inhaler, for example capable of being loaded with a unit dose capsule or cartridge. Exemplary inhalers are disclosed in US 2009/0308392 Dry Powder Inhaler and System for Drug Delivery which is hereby incorporated by reference in its entirety. In various embodiments, the inhaler is a dry powder inhaler. In some embodiments, the dry powder comprises microparticles of a diketopiperazine, for example a 2,5-diketo-3,6-bis(N—X-4-aminobutyl)piperazine, wherein X is fumaryl, succinyl, maleyl, or glutaryl. In some embodiments, the dry powder is a medicament comprising an active agent, for example a small molecule drug, biologic, polypeptide, peptide, protein, hormone, insulin or insulin analog, glucagon-like peptide 1 or analog thereof, parathyroid hormone or active fragment or analog thereof, oxyntomodulin, peptide YY, oxytocin, analgesic, opioid, triptan, antibiotic, antibody, or vaccine.

Some embodiments comprise a cover according to any of the embodiments disclosed herein mounted on the mouthpiece of an inhaler into which has been loaded a cartridge or capsule containing a medicament, for example a dry powder medicament. The inhaler can be in an open, capsule- or cartridge-loading position. Alternatively the inhaler can be in a closed, dosing position.

Further embodiments include methods of using the inhaler comprising opening an inhaler with the cover mounted on the mouthpiece so that a medicament-containing capsule or cartridge can be loaded into the inhaler, loading the inhaler with the capsule or cartridge, closing the inhaler, and removing the cover. Other embodiments comprise a step of inhaling the medicament through the mouthpiece. Other embodiments comprise a step of remounting the cover on the mouthpiece.

In some embodiments, deformable mouthpiece covers can also be provided for inhalers. These deformable covers can be made from an elastomeric material. In these embodiments, the mouthpiece cover creates a suction-fit with the mouthpiece of an inhaler and prevents easy removal or inhalation of the cover while mounted in an inhaler.

Embodiment 1

A cover for an inhaler mouthpiece, the cover comprising: a substantially hollow body configured to be insertable onto the inhaler mouthpiece; a grip-tab configured for handling the cover during placing said cover onto said inhaler mouthpiece and removing said cover from said inhaler; an internal surface comprising ridges and detents which promote a tight fitting of said cover on said inhaler mouthpiece; an external surface; and a beveled front wall configured to prevent a subject from inhaling said cover when the cover is mounted on said inhaler mouthpiece.

Embodiment 2

The cover of Embodiment 1, wherein the grip-tab includes rib-like or ridge structures.

Embodiment 3

The cover of Embodiment 1 or 2, wherein said grip-tab is substantially flat.

Embodiment 4

The cover of Embodiment 1, 2, or 3, wherein said grip-tab extends outwardly and laterally from said inhaler mouthpiece.

Embodiment 5

The cover of Embodiment 1, 2, 3, or 4, wherein when mounted in said inhaler mouthpiece, the cover prevents a user from closing his or her lips.

Embodiment 6

The cover of Embodiment 1, 2, 3, 4, or 5, wherein the body has a tapered end.

Embodiment 7

The cover of Embodiment 1, 2, 3, 4, 5, or 6, wherein the beveled wall has an obtuse angle.

Embodiment 8

The cover of Embodiment 7, wherein the obtuse angle is greater than about 95 degrees.

Embodiment 9

The cover of Embodiment 1, 2, 3, 4, 5, 6, 7, or 8, wherein the body having an opening to an internal volume and a closed end that contacts an inhaler mouthpiece outlet.

Embodiment 10

The cover of Embodiment 1, 2, 3, 4, 5, 6, 7, 8, or 9, wherein the grip-tab has a rectilinear shape.

Embodiment 11

The cover of Embodiment 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10, wherein the grip-tab has a trapezoidal shape.

Embodiment 12

The cover of Embodiment 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or 11, wherein the grip-tab has a width and the inhaler mouthpiece has a width and the width of the grip-tab is greater than 20% wider than the width of the inhaler mouthpiece.

Embodiment 13

The cover of Embodiment 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, or 12, wherein ridges and detents are configured to provide the cover that is removable using a pinch grip force of less than 10 pounds.

Embodiment 14

The cover of Embodiment 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, or 13, wherein ridges and detents are configured to provide the cover that is removable using a pinch grip force of less than 6 pounds.

Embodiment 15

The cover of Embodiment 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, or 14, wherein ridges and detents are configured to provide the cover that is removable by a user with diminished grip strength.

The preceding disclosures are illustrative embodiments. The figures present a preferred embodiment comprising a combination of the features disclosed herein. Additional embodiments contemplated comprise the various sub-combinations of these features and the incorporation of additional features or variations disclosed herein. It should be appreciated by those of skill in the art that the devices, techniques and methods disclosed herein elucidate representative embodiments that function well in the practice of the present disclosure. However, those of skill in the art should, in light of the present disclosure, appreciate that many changes can be made in the specific embodiments that are disclosed and still obtain a like or similar result without departing from the spirit and scope of the invention.

Unless otherwise indicated, all numbers expressing quantities of ingredients, properties such as molecular weight, reaction conditions, and so forth used in the specification and claims are to be understood as being modified in all instances by the term “about.” Accordingly, unless indicated to the contrary, the numerical parameters set forth in the following specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained by the present invention. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements.

The terms “a” and “an” and “the” and similar referents used in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. Recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g. “such as”) provided herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention.

The use of the term “or” in the claims is used to mean “and/or” unless explicitly indicated to refer to alternatives only or the alternatives are mutually exclusive, although the disclosure supports a definition that refers to only alternatives and “and/or.”

Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member may be referred to and claimed individually or in any combination with other members of the group or other elements found herein. It is anticipated that one or more members of a group may be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is herein deemed to contain the group as modified thus fulfilling the written description of all Markush groups used in the appended claims.

Preferred embodiments of this invention are described herein, including the best mode known to the inventors for carrying out the invention. Of course, variations on those preferred embodiments will become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventor expects those of ordinary skill in the art to employ such variations as appropriate, and the inventors intend for the invention to be practiced otherwise than specifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context.

Specific embodiments disclosed herein may be further limited in the claims using consisting of or consisting essentially of language. When used in the claims, whether as filed or added per amendment, the transition term “consisting of” excludes any element, step, or ingredient not specified in the claims. The transition term “consisting essentially of” limits the scope of a claim to the specified materials or steps and those that do not materially affect the basic and novel characteristic(s). Embodiments of the invention so claimed are inherently or expressly described and enabled herein.

Furthermore, numerous references have been made to patents and printed publications throughout this specification. Each of the above cited references and printed publications are herein individually incorporated by reference in their entirety.

Further, it is to be understood that the embodiments of the invention disclosed herein are illustrative of the principles of the present invention. Other modifications that may be employed are within the scope of the invention. Thus, by way of example, but not of limitation, alternative configurations of the present invention may be utilized in accordance with the teachings herein. Accordingly, the present invention is not limited to that precisely as shown and described. 

We claim:
 1. A cover for an inhaler mouthpiece, the cover comprising: a substantially hollow body including a front end and a back end, wherein the hollow body is configured to be insertable onto the inhaler mouthpiece; an external surface including a top surface, a first side surface extending from the front end to the back end, a second side surface extending from the front end to the back end, a substantially flat bottom surface, and a beveled front surface extending between the top surface and the substantially flat bottom surface; a grip-tab configured for handling the cover during placing said cover onto said inhaler mouthpiece and removing said cover from said inhaler mouthpiece, wherein the grip-tab extends outwardly from a location where the beveled front surface and the bottom surface meet at the front end and wherein the grip-tab includes a flat grip-tab bottom surface congruent and co-planar with the substantially flat bottom surface and the grip-tab further comprises a flat grip-tab top surface; and an internal surface comprising protrusions configured to promote a tight fitting of said cover on said inhaler mouthpiece; wherein the beveled front surface is configured to prevent a subject from inhaling said cover when the cover is mounted on said inhaler mouthpiece, and wherein the flat grip-tab bottom surface has a trapezoidal shape and the flat grip-tab top surface has a trapezoidal shape.
 2. The cover of claim 1, wherein the grip-tab includes rib or ridge structures.
 3. The cover of claim 1, wherein said grip-tab is substantially flat.
 4. The cover of claim 1, wherein said grip-tab extends outwardly and laterally from said inhaler mouthpiece.
 5. The cover of claim 1, wherein when mounted on said inhaler mouthpiece, the cover is configured to prevent a user from closing his or her lips.
 6. The cover of claim 1, wherein the substantially hollow body has a tapered end.
 7. The cover of claim 1, wherein the beveled front surface has an obtuse angle.
 8. The cover of claim 7, wherein the obtuse angle is greater than about 95 degrees.
 9. The cover of claim 1, wherein the substantially hollow body having an opening to an internal volume and a closed end that contacts an inhaler mouthpiece outlet.
 10. The cover of claim 1, wherein the grip-tab has a rectilinear shape.
 11. The cover of claim 1, wherein the grip-tab has a width and the inhaler mouthpiece has a width and the width of the grip-tab is 20% greater than the width of the inhaler mouthpiece.
 12. The cover of claim 1, wherein the protrusions are configured to provide a pinch grip removal force of less than 10 pounds.
 13. The cover of claim 1, wherein the protrusions are configured to provide a pinch grip removal force of less than 6 pounds.
 14. The cover of claim 1, wherein the top surface extends to the front end but not to the back end. 